Feasibility of Providing a Purpose Renewal Intervention for Cancer Survivors Via Virtual Groups (CC-V)

The Compass Course (CC) is a group intervention designed for individuals with Breast Cancer. Over the course of 8 face-to-face group sessions, the CC is designed to help participants reclaim a sense of self-grounded purpose in daily life, defined as intentional use of time and energy in ways that align with one's values, strengths, and sources of personal meaning (e.g., inner compass) in the moments that compose a day. Because of COVID-19, in-person groups are discouraged and so we need to identify new ways to provide group-based interventions that are feasible and efficacious.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasm
• Intervention / Treatment: Other: Compass Course

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55447
      • Abbott Northwestern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able to attend intervention sessions for 9 weeks on Monday or Tuesday afternoons (4:30 - 6:30 pm) starting Monday, April 5, 2021
2. 25 years of age or older
3. Completed chemotherapy and/or radiation treatment for Stage 0, 1, 2, or 3 breast cancer at least 2 months prior to participating in the Compass Course intervention
4. English speaking
5. Graduated from high school
6. Able to see, hear, speak (with or without assistive devices)
7. Able to provide own transportation to sessions
8. Willing and able to commit to attend all 8 intervention sessions
9. Access to computer or tablet and adequate internet connection to participate in video conference

Exclusion Criteria:

1. Stage 4 breast cancer or any other cancer
2. Actively receiving chemotherapy or radiation treatments for cancer. (However, patients may be on Herceptin and/or endocrine treatment and participate in the study.)
3. History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning
4. Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Compass Course; Virtual Compass Course	Other: Compass Course; The Compass Course is an 8-session group course designed to address purpose in life of those with Breast Cancer. Enrollment in this arm will involve participation in the Compass Course virtually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Scales of Psychological Wellbeing	A widely-used self-report questionnaire that was designed to measure 6 theoretically motivated dimensions of psychological well-being (autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, self-acceptance).	Through Study Completion (about 4 Months)
Change in Meaning in Life Questionnaire	A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).	Through Study Completion (about 4 Months)
Change in Engagement in Meaningful Activities survey	A 12-item self-report questionnaire designed to measure the extent to which a person experiences meaningfulness in his/her daily life activities.	Through Study Completion (about 4 Months)
Change in Purpose Status Question	A single forced-choice self-report screener question that we developed in order to characterize existential distress related to purpose in life.	Through Study Completion (about 4 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Depression Inventory -- II	A 21-question, widely-used self-report rating inventory that measures characteristic attitudes and symptoms of depression.	Through Study Completion (about 4 Months)
Change in State-Trait Anxiety Inventory	A self-report questionnaire composed of 20 state and 20 trait statements related to anxiety. We will use the 20-item State inventory (1-4 scale).	Through Study Completion (about 4 Months)

Collaborators and Investigators

• Sponsor: Mary Radomski
• Investigators: Principal Investigator: Mary V Radomski, OTR/L, PhD, Senior Scientific Advisor

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Purpose
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CKRC2021-CCV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No